Methods and devices for protecting nasal turbinate during surgery

ABSTRACT

Devices and methods are provided which shield at least one turbinate from trauma or damage during sinus surgery that could be caused by direct contact with diagnostic and therapeutic devices. The devices and methods provided are particularly useful for protecting nasal turbinates during FESS and FTIS procedures.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to methods and devices for protecting nasalturbinates during surgery.

BACKGROUND OF THE INVENTION

The skull contains a series of cavities known as paranasal sinuses thatare connected by passageways. The paranasal sinuses include frontalsinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. Theparanasal sinuses are lined with mucous-producing mucosal tissue andultimately open into the nasal cavity. Normally, mucous produced by themucosal tissue slowly drains out of each sinus through an opening knownas an ostium. If the mucosal tissue of one of these passageways becomesinflamed for any reason, the cavities which drain through thatpassageway can become blocked. This blockage can be periodic (resultingin episodes of pain) or chronic. This interference with drainage ofmucous (e.g., occlusion of a sinus ostium) can result in mucosalcongestion within the paranasal sinuses. Chronic mucosal congestion ofthe sinuses can cause damage to the epithelium that lines the sinus withsubsequent decreased oxygen tension and microbial growth (e.g., a sinusinfection).

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses caused by bacteria, viruses, fungi (molds),allergies or combinations thereof. It has been estimated that chronicsinusitis (e.g., lasting more than 3 months or so) results in 18 millionto 22 million physician office visits per year in the United States.Patients who suffer from sinusitis typically experience at least some ofthe following symptoms: headaches or facial pain; nasal congestion orpost-nasal drainage; difficulty breathing through one or both nostrils;bad breath; and/or pain in the upper teeth.

One of the ways to treat sinusitis is by restoring the lost mucous flow.The initial therapy is typically drug therapy using anti-inflammatoryagents to reduce the inflammation and antibiotics to treat theinfection. A large number of patients do not respond to drug therapy.Currently, the gold standard for patients with chronic sinusitis that donot respond to drug therapy is a corrective surgery called FunctionalEndoscopic Sinus Surgery (FESS).

During FESS, an endoscope is inserted into the nose and, undervisualization through the endoscope, the surgeon may remove diseased orhypertrophic tissue or bone and may enlarge the ostia of the sinuses torestore normal drainage of the sinuses. FESS procedures are typicallyperformed with the patient under general anesthesia.

Although FESS continues to be the gold standard therapy for surgicaltreatment of severe sinus disease, FESS does have several shortcomings.For example, FESS can cause significant post-operative pain. Also, someFESS procedures are associated with significant postoperative bleedingand, as a result, nasal packing is frequently placed in the patient'snose for some period of time following the surgery. Such nasal packingcan be uncomfortable and can interfere with normal breathing, eating,drinking etc. Also, some patients remain symptomatic even after multipleFESS surgeries. Additionally, some FESS procedures are associated withrisks of iatrogenic orbital, intracranial and sinonasal injury. Manyotolaryngologists consider FESS an option only for patients who sufferfrom severe sinus disease (e.g., those showing significant abnormalitiesunder CT scan). Thus, patients with less severe disease may not beconsidered candidates for FESS. One of the reasons why FESS procedurescan be bloody and painful relates to the fact that instruments havingstraight, rigid shafts are used. In order to target deep areas of theanatomy with such straight rigid instrumentation, the physician needs toresect and remove or otherwise manipulate any anatomical structures thatmay lie in the direct path of the instruments, regardless of whetherthose anatomical structures are part of the pathology.

New devices, systems and techniques are being developed for thetreatment of sinusitis and other disorders of the ear, nose, throat andparanasal sinuses. For example, various catheters, guidewires and otherdevices useable to perform minimally invasive, minimally traumatic ear,nose and throat surgery have been described in U.S. patent applicationSer. No. 10/829,917 entitled “Devices, Systems and Methods forDiagnosing and Treating Sinusitis and Other Disorders of the Ears, Noseand/or Throat,” issed Feb. 2, 2010 as U.S. Pat. No. 7,654,997, Ser. No.10/912,578 entitled “Implantable Device and Methods for Delivering Drugsand Other Substances to Treat Sinusitis and Other Disorders,” issuedApr. 22, 2008 as U.S. Pat. No. 7,361,168, Ser. No. 10/944,270 entitled“Apparatus and Methods for Dilating and Modifying Ostia of ParanasalSinuses and Other Intranasal or Paranasal Structures”, published Jan. 5,2006 as U.S. Pub. No. 2006/0004323, Ser. No. 11/037,548 entitled“Devices, Systems and Methods For Treating Disorders of the Ear, Noseand Throat”, issued Dec. 9, 2008 as U.S. Pat. No. 7,462,175, and Ser.No. 11/116,118 entitled “Methods and Devices For Performing ProceduresWithin the Ear, Nose, Throat and Paranasal Sinuses”, issued May 18, 2010as U.S. Pat. No. 7,720,521. Each of these applications is herebyincorporated herein, in its entirety, by reference thereto. Many ofthese new devices, systems and techniques are useable in conjunctionwith endoscopic, radiographic and/or electronic assistance to facilitateprecise positioning and movement of catheters, guidewires and otherdevices within the ear, nose, throat and paranasal sinuses and to avoidundesirable trauma or damage to critical anatomical structures such asthe eyes, facial nerves and brain.

For example, in one new procedure (referred to in this patentapplication as a “Flexible Transnasal Sinus Intervention” or FTSI), adilatation catheter (e.g., a balloon catheter or other type of dilator)is advanced through the nose to a position within the ostium of aparanasal sinus or other location, without requiring removal or surgicalalteration of other intranasal anatomical structures. The dilatationcatheter is then used to dilate the ostium or other anatomicalstructures to facilitate natural drainage from the sinus cavity. In somecases, a tubular guide may be initially inserted through the nose andadvanced to a position near the sinus ostium and a guidewire may then beadvanced through the tubular guide and into the affected paranasalsinus. The dilatation catheter may then be advanced over the guidewireand through the tubular guide to a position where its dilator (e.g.,balloon) is positioned within the sinus ostium. The dilator (e.g.,balloon) is then expanded causing the ostium to dilate. In some cases,such dilatation of the ostium may fracture, move or remodel bonystructures that surround or are adjacent to the ostium. Optionally, insome procedures, irrigation solution and/or therapeutic agents may beinfused through a lumen of the dilatation catheter and/or other workingdevices (e.g., guidewires, catheters, cannula, tubes, dilators,balloons, substance injectors, needles, penetrators, cutters, debriders,microdebriders, hemostatic devices, cautery devices, cryosurgicaldevices, heaters, coolers, scopes, endoscopes, light guides,phototherapy devices, drills, rasps, saws, etc.) may be advanced throughthe tubular guide and/or over the guidewire to deliver other therapy tothe sinus or adjacent tissues during the same procedure in which theFTSI is carried out. In FTSI procedures that include positioning of aguidewire into a paranasal sinus, the placement of the guidewire istypically confirmed by visualizing the procedure under fluoroscopy orother x-ray visualization techniques. It is to be understood that, inFTSI procedures, structures and passageways other than sinus ostia maybe dilated using the tools described above, tissue may be resected orablated, bone may be restructured, drugs or drug delivery systems may bedeployed, etc., as described in the documents incorporated herein byreference. Thus, for the purposes of this application the term FTSI willbe generally used to refer broadly to all of those procedures, not justdilation of sinus ostia.

A turbinate (or nasal conchae) is a long, narrow and curled bone shelfwhich protrudes into the breathing passage of the nose. Turbinatesdivide the nasal airway into three groove-like air passages- and areresponsible for forcing inhaled air to flow in a steady, regular patternaround the largest possible surface of cilia and climate controllingtissue. Turbinates are composed of pseudo-stratified columnar ciliatedrespiratory epithelium with a thick, vascular and erectile glandulartissue layer. The turbinates are located laterally in the nasalcavities, curling medially and downwards into the nasal airway. Thereare three pairs of turbinates, the superior, middle and inferiorturbinate pairs. Each pair is composed of one turbinate in either sideof the nasal cavity, divided by the septum.

Aside from being responsible for nasal airflow and required forfunctional respiration, the turbinates are also responsible forfiltration, heating and humidification of air inhaled through the nose.As air passes over the turbinate tissues it is heated to bodytemperature, humidified and filtered. The respiratory epithelium of theturbinates plays a major role in the body's immunological defense. Therespiratory epithelium of the turbinates are partially composed ofgoblet cells which secret mucus over the nasal cavities which filtersout foreign particals larger than 2 to 3 micrometers. The respiratoryepithelium of the turbinates is also involved in the lymphatic systemwhich protects the body from being infected by viruses and/or bacteria.

Both the FESS and FTSI procedures may cause damage to one or more nasalturbinates while navigating the paranasal passageway to and from thesurgical target site. Damaging a turbinate may cause pain and/orbleeding which can interfere with the surgical procedure and can alsoincrease the recovery time for the patient.

Some devices have been developed which position a portion of the middleturbinate against the nasal septum prior to endoscopic surgery. Thistype of nasal splint increases visualization of the nasal cavities tofacilitate nasal endoscopic surgery and protects a portion of the middleturbinate from endoscopic tools during surgery by moving orrepositioning the middle turbinate against the nasal septum.Unfortunately, these devices require being secured to the nasal septumas well as moving the middle turbinate against the nasal septum whichmay not be feasible if the turbinate is large or swollen which couldlead to blockage of nasal breathing. For examples, see U.S. Pat. No.5,599,284, “Pre-operative nasal splint for endoscopic sinus surgery andmethod” to Shea, John P, and U.S. Pat. No. 5,713,839, “Pre-operativenasal splint for endoscopic sinus surgery and method” to Shea, John P.Another drawback to these types of splints is that it many not bepossible to reposition the turbinate without fracturing it.

Turbinate splints have also been developed and are commonly used asnasal post-operative devices, for example, see U.S. Pat. No. 5,350,396,“Nasal Splint” to Eliachar. These types of splints address particularproblems encountered after nasal septal reconstructive surgery. They areusually utilized to support the septum in the correct position duringhealing and recovery after surgery. Other types of post-operativeturbinate splints have been an asset in insuring a more completeseparation of the nasal mucosal membranes after surgery or injury, butnone of the post-operative nasal splints are configured to be utilizedduring FESS and FTSI procedures to protect a nasal turbinate from traumaor damage from surgical instruments.

Currently, there are no devices or methods for protecting nasalturbinates, in their natural position, prior to or during sinus surgery.Thus there is a need for methods and devices that can protect nasalturbinates during sinus surgery, and in particular, FESS and FTSIprocedures.

SUMMARY OF THE INVENTION

The invention provides apparatus and methods for the protection of nasalturbinates during surgical operations. The apparatus of the inventioncomprise, in general terms, a first protecting portion; a secondprotecting portion; and a bridge portion joined to the first and secondprotecting portions.

In many embodiments the first and second protecting portions eachinclude a proximal end portion, the proximal end portions joined to thebridge portion.

In many embodiments the first protecting portion is structured andconfigured to protect a first side of a turbinate, the second protectingportion is structured and configured to protect a second side of aturbinate, and the bridge portion is structured and configured toprotect an anterior or inferior portion of the turbinate.

In certain embodiments the first and second protecting portions aresubstantially planar in shape.

In certain embodiments the first and second protecting portions eachinclude a distal end portion, the distal end portions each having arounded shape, the rounded shapes defining atraumatic surfaces.

In certain embodiments the bridge portion is resilient and the first andsecond protecting portions are movable with respect to the bridgeportion.

In certain embodiments the bridge portion is malleable and the first andsecond protecting portions are movable with respect to the bridgeportion.

In certain embodiments the first and second protecting portions andbridge portions are joined together in a configuration that defines anangle between the first and second protecting portions of between about25° and about 45°.

In certain embodiments the bridge portion further comprises at least onecrease, the crease configured to increase resiliency of the bridgeportion.

In certain embodiments the bridge portion further comprises at least onecrease, the crease configured to increase malleability of the bridgeportion.

In certain embodiments the first and second protecting portions andbridge portion further comprise an inner surface structured andconfigured to contact a turbinate.

In certain embodiments the inner surface includes a biocompatibleadhesive.

In certain embodiments the first and second protecting portions andbridge portion further comprise an outer surface structured andconfigured to deflect a surgical instrument.

In certain embodiments the first and second protecting portions eachinclude at least one slot structured and configured to facilitategrasping of the first and second portions by a surgical instrument.

In certain embodiments the first and second protecting portions arereversibly movable from or between an open position to a closedposition.

In certain embodiments the first and second protecting portions aremovable to an open position by application of an opening force to thefirst and second protecting portions, and movable to a closed positionby removal of the opening force from the first and second protectingportions.

In certain embodiments the first and second protecting portions aremovable to an open position by application of an opening force to thebridge portion, and movable to a closed position by removal of theopening force from the bridge portion.

In certain embodiments the turbinate protector further comprising afirst control element and a second control element, the first and secondcontrol elements mechanically coupled to the first and second protectingportion through the bridge portion.

In certain embodiments the first and second control elements arestructured and configured such that application of an opening force tothe first and second control elements causes the first and secondprotecting portions to move apart to an open position, and removal ofthe opening force from the first and second control elements results inthe first and second portions moving together to a closed position.

In certain embodiments the first and second control elements arestructured and configured such that application of an opening force tothe first and second control elements causes distal end portions of thefirst and second protecting portions to move apart to an open position,and removal of the opening force from the first and second controlelements results in the distal end portions of the first and secondportions moving together to a closed position.

In certain embodiments the first control element comprises first andsecond control segments, and the second control element comprises firstand second control segments, the first and second control segments ofeach control element being mechanically coupled to each other.

In certain embodiments the bridge portion is structured and configuredsuch that applying an opening force to the bridge element results in thefirst and second portions moving apart from each other to an openposition, and removing the opening force from the bridge portion resultsin the first and second portions moving together to a closed position.

In certain embodiments the bridge portion is structured and configuredsuch that applying an opening force to the bridge element results in adistal end portion of the first portion and a distal end portion of thesecond portion moving apart from each other to an open position, andremoving the opening force from the bridge portion results in the distalend portions of the first and second portions moving together to aclosed position.

In certain embodiments the bridge portion is arcuate in shape and isjoined to the first and second portions by first and second connectingregions, the bridge and connecting regions structured and configuredsuch that applying an opening force to the bridge element results in adistal end portion of the first portion and a distal end portion of thesecond portion moving apart from each other to an open position, andremoving the opening force from the bridge portion results in the distalend portions of the first and second portions moving together to aclosed position.

In certain embodiments the turbinate protector further comprises atleast one radio-opaque marker thereon.

The invention also provides methods for protecting nasal turbinatesduring surgical procedures. The methods comprise, in general terms:introducing a turbinate protector into a patient; locating a targetturbinate; positioning a turbinate protector on the target turbinate;performing paranasal surgery; and removing the turbinate protector fromthe patient.

In certain embodiments the introducing of the turbinate protectorcomprises inserting the turbinate protector through the nasal passage ofthe patient.

In certain embodiments the locating comprises visualizing the selectedor target turbinate via endoscopic imaging.

In certain embodiments the locating comprises visualizing the selectedor target turbinate by fluoroscopic imaging utilizing a radio-opaquemarker on the turbinate protector.

In certain embodiments the positioning comprises: positioning a firstprotecting portion of the turbinate protector adjacent to a first sideof the turbinate; positioning a second protecting portion of theturbinate protector adjacent to a second side of the turbinate; andpositioning a bridge region of the turbinate protector adjacent to theanterior or inferior portion of the turbinate.

In certain embodiments the positioning further comprises contacting theturbinate with an inside surface of the turbinate protector.

In certain embodiments the methods may further comprise securing theinside surface of the turbinate protector to the turbinate with abioadhesive located on the inner surface.

In certain embodiments the positioning comprises: moving the first andsecond protecting portions of the turbinate protector to an openposition; positioning the target turbinate between the first and secondprotecting portions; and moving the first and second protecting portionsto a closed position.

In certain embodiments the positioning further comprises: applying anopening force to the first and second protecting portions to move thefirst and second portions to the open position; and removing the openingforce from the first and second protecting portions, to move the firstand second protecting portions to the closed position.

In certain embodiments the positioning further comprises: applying anopening force to the bridge portion to move the first and secondportions to the open position; and removing the opening force from thebridge portion, to move the first and second protecting portions to theclosed position.

In certain embodiments the positioning further comprises: positioningthe first protecting portion adjacent to a first side of the turbinate;positioning the second protecting portion adjacent to a second side ofthe turbinate; and positioning the bridge portion adjacent to ananterior or inferior portion of the turbinate.

In certain embodiments the positioning further comprises: applying anopening force to first and second control elements, the first and secondcontrol elements being mechanically coupled to the first and secondprotecting portions; and removing the opening force from the controlelements.

In certain embodiments the performing paranasal surgery comprisesperforming FESS surgery.

In certain embodiments the performing paranasal surgery comprisesperforming FTSI surgery.

In certain embodiments the removing comprises opening the first andsecond protecting portions; releasing the turbinate from the turbinateprotector; and withdrawing the turbinate protector from the patientnasal cavity via the nostril.

Further features of the invention will become apparent to those personsskilled in the art upon reading the details of the devices, methods andsystems as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross sectional view of a human paranasal passageway showingthe superior, middle, and inferior turbinates and their positioning inrelation the frontal and sphenoid nasal sinuses.

FIG. 2 is a cross sectional view of a human nasal passageway showing thesuperior, middle, and inferior turbinates in cross section, as well astheir positioning in relation the frontal and sphenoid nasal sinusostia.

FIG. 3 a-d are top, front, perspective and side views respectively of anembodiment of a turbinate protector in accordance with the invention.

FIG. 4 is a cross-sectional view of a human nasal passageway showing oneembodiment of a turbinate protector positioned over the middle turbinateof a patient in accordance with the invention.

FIG. 5 is an endoscopic view of a human nasal passageway showing amiddle turbinate and the region of the middle turbinate that would beprotected by the turbinate protector and turbinate protecting methods ofthe invention.

FIG. 6 a-c show one embodiment of a turbinate protector respectively inan extended position, in a folded position, and positioned for graspingwith forceps.

FIG. 7 a and 7 b respectively show side views of another embodiment of aturbinate protector in opened and closed positions.

FIG. 8 a and 8 b respectively show another embodiment of a turbinateprotector in closed and open positions.

FIG. 9 is a side view of still another embodiment of a turbinateprotector in accordance with the invention.

FIG. 10 is a perspective view of yet another embodiment of a turbinateprotector in accordance with the invention.

FIG. 11 is a flow chart showing a method for protecting a turbinate inaccordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

Before the present devices and methods are described, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “atube” includes a plurality of such tubes and reference to “the shaft”includes reference to one or more shafts and equivalents thereof knownto those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Referring first to FIG. 1, a cross section of a patient's paranasalpassageway is shown with the superior turbinate 10 near the ostium 15 ofthe sphenoid sinus 20, an inferior turbinate 30, a middle turbinate 40shown with a middle meatus 50 therebetween, a frontal sinus 60, and theEustachian tube opening 70. The ostium (not shown) of the frontal sinus60 is obstructed in this illustration by the middle turbinate 40. Theinferior turbinates 30 are the largest turbinates, being about 3 inchesin length, and are responsible for the majority of airflow direction,humidification, heating, and filtering of air inhaled through the nose.The middle turbinates 40 are smaller and are about two inches in length.The middle turbinates 40 project downwards over the openings of themaxillary and ethmoid sinuses, and act as buffers to protect the sinusesfrom coming in direct contact with pressurized nasal airflow. Mostinhaled airflow travels between the inferior turbinate and the middleturbinate 40. The superior turbinates 10 are smaller structures,connected to the middle turbinates by nerve-endings, and serve toprotect the olfactory bulb.

During nasal surgery, surgical devices may be inserted through the nasalopening 80 of the nose to perform corrective surgical operations. Suchdevices can damage portions of the inferior 30 and middle turbinates 40as the user of the surgical devices navigates the surgical devicesthrough the paranasal passageway to the surgical site. The anteriorportion of the middle turbinate 40 is vulnerable to trauma by surgicaldevices in most types of sinusitis surgeries, and in particular, whenthe surgery involves opening the frontal sinus ostium and/or navigatingsurgical devices through the frontal sinus ostium.

FIG. 2 shows the view of a patient's paranasal passageway of FIG. 1, butwith portions of the superior 10, middle 40 and inferior 30 turbinatesshown in cross section to more clearly illustrate the location of sinusostia and other nasal ostia with respect to the nasal turbinates. Themiddle turbinate 40 obscures the frontal sinus ostia 90 as well asopenings 100 to the anterior ethmoid cells, openings 110 to the middleethmoid cells, and the maxillary sinus ostium 120, thus increasing thechances of trauma to the middle turbinate 40 when access to theseopenings, particularly the frontal sinus ostium, is needed duringsurgery. The superior turbinate 10 is vulnerable to trauma by surgicaldevices particularly when the openings 130 of the posterior ethmoidcells or the sphenoid ostium 15 must be navigated by surgical devices orare the site of the surgical procedure, such as enlarging the sphenoidostia by a balloon catheter, for example. The inferior turbinate 30 ismost likely to be damaged during procedures involving the nasalcranialduct 150 located behind the inferior turbinate 30.

Referring now to FIGS. 3 a-d, one embodiment of a turbinate protector200 is shown in accordance with the invention. FIGS. 3 a and 3 brespectively provide a top view and a front view of a turbinateprotector 200 configured to help protect the middle turbinate fromtrauma by surgical instruments during a sinus surgical procedure. FIGS.3 c and 3 d are respectively a perspective view and a side view of theturbinate protector 200 of FIG. 3 a and FIG. 3 b. Turbinate protector200 comprises a first substantially planar portion, member, wing or flap210 and a second substantially planar portion, member, wing or flap 220.The first and second substantially planar portions 210, 220 each have aproximal end portion 230 a, 240 a respectively, and a distal end portion230 b and 240 b respectively. The proximal end portions 230 a and 240 aof portions 210 and 220 are joined or connected to one another by aresilient, bendable or malleable portion, bridge or connecting region250.

FIG. 3 a is shown with the middle turbinate 40 of a patient positionedbetween portions 210, 220 of turbinate protector 200. When positioned inthe paranasal cavity, the first and second portions 210, 220 ofturbinate protector 200 are configured to be positioned adjacent to theopposite the sides of the middle turbinate 40 and protect the sides(i.e. left or right side) of the turbinate. The malleable portion 250 isconfigured to protect the anterior portion and/or inferior portion ofthe middle turbinate 40. The bridge portion 250 and side portions 210,220 thus define or provide a “tent”-shaped protector for the turbinate40, with portions 210, 220 serving as protecting members or elements forthe sides of turbinate, and with bridge or connector 250 serving as aprotecting member or element for anterior and/or inferior portions ofturbinate 40. Portion 250 defines a rounded, atraumatic surface thatavoids or minimizes damage or irritation to tissue to which portion 250may contact. Distal end portions 230 b, 240 b are also atraumatic andmay be rounded in shape as shown more particularly in FIGS. 3 c and 3 d,to provide atraumatic surfaces.

While the turbinate protector 200 is shown in association with themiddle turbinate 40, it should be understood that the invention may beused to protect other turbinates or other portions of the paranasalcavity. Thus, while the first and second portions 210 and 220 are shownas having generally the same length or size with respect to each other,the planar portions 210 and 220, as well as the bendable portion 250,may be varied in size and shape according to the type or shape of theturbinate to be protected.

In some embodiments of the invention, the protector 200 comprises atleast one crease, slot or indent 260 (FIG. 3 b) proximate to the bridgeportion 250. The creases 260 are configured to increase the resiliencyor malleability of portion 250 and aid the user or surgeon in placingthe protector 200 over the turbinate with a surgical device such as apair of forceps. The crease(s) 260 may also be configured to move, bendor otherwise reconfigure the substantially planar portions 210 and 220to their respective left or right sides of the turbinate beingprotected.

FIG. 3 c illustrates the overall “winged” shape of the turbinateprotector 200, with the distal end portions 230 b and 240 b of thesubstantially flat portions 210 and 220 angled away from each other. Theangle or dihedral defined by portions 210, 220 and the malleable portion250 may vary depending on the shape of the turbinate to be protected. Ingeneral, the angle defined by portions 210, 220 and the malleableportion 250 may range, for example, from about 120 degrees to about 10degrees. More preferably, then angle will range from about 60 degrees toabout 20 degrees.

The turbinate protector 200 comprises an inner side 270 and outer sidesurfaces 280. The inner side surface 270 is configured to contact themiddle turbinate 40, and the outer side 280 is configured to disperse ordeflect forces generated by the impact of a surgical instrument (notshown) when the surgical instrument comes in contact the turbinateprotector 200. By dispersing the forces generated by the impact of asurgical instrument, the turbinate protector 200 shields the middleturbinate 40 from direct contact with the surgical instrument andprevents or reduces the amount of trauma that would otherwise be causedby the surgical instrument. Inner side 270 surface may further comprisea coating of a biocompatible (and, optionally, biodegradable) adhesiveto aid in the positioning and securing of the turbinate protector 200 onthe turbinate 40. Such biocompatible adhesives that may be used includebut are not limited to cyanoacrylates, collagen-, carbohydrate- and/orprotein-based adhesives.

In some embodiments turbinate protector 200 may include one or moreradio-opaque markers 285 to allow the surgeon user to visualize andposition the turbinate protector 200 by fluoroscopy or other x-raytechniques during surgery. The marker 285 may alternatively be made ofelectromagnetic, piezoelectric or magnetic materials, depending of thevisual navigational technique being utilized during the surgicalprocedure.

Turbinate protector 200 may be manufactured from various resilientand/or malleable materials which allow the turbinate protector to bebent or formed around a portion of the middle turbinate most susceptibleto trauma by surgical instruments. In general, the turbinate protectorsof the invention are made of thin, resilient polymeric materials capableof dispersing force and pressure over a larger area to aid in thereduction of friction and/or chafing from surgical instruments. Suitablebiocompatible material(s) that can be used for construction of aturbinate protecting device include but are not limited to metals e.g.malleable stainless steel, fully annealed stainless steel, copper,aluminum, titanium, nickel-titanium alloy (e.g., Nitinol), etc.;polymers e.g., polyether block amides (e.g., Pebax), polyether etherketone (PEEK), Nylon, polyethylene, polyimide, polyurethane,polytetrafluoroethylene (PTFE), etc., or bioabsorbable materials such aspolymers based on polycaprolactone, polyglycolic acid (PGA), polylacticacid (PLA), or copolymers of PGA and PLA. In certain embodiments thebridge portion 20 may comprise a malleable material such as annealedstainless steel, while wing portions 210, 220 are made of a resilientmaterial.

The turbinate protector 200 is anatomically shaped and can be placedover a variety of turbinate sizes and shapes, including pneumatizedturbinates. The embodiments of the turbinate protectors disclosed hereinare especially configured for the middle turbinate when treating themaxillary, frontal, and/or sphenoid sinuses via balloon sinuplasty. Asnoted above, the configuration of the turbinate protectors of theinvention may be varied as required to protect different turbinates orturbinate surfaces.

FIG. 4 is a cross-sectional view of a human nasal passageway showing oneembodiment of a turbinate protector positioned over the middleturbninate 40 of a patient in accordance with methods of the invention.Prior to sinus surgery of the maxillary sinus, the turbinate protector200 is introduced through the nasal passageway through a nostril andpositioned on a section of the anterior/inferior portion of the middleturbinate 40. After positioning the turbinate protector 200, a guidecatheter 310 is introduced into the patient via a nostril and ispositioned in the maxillary sinus ostium (not shown), located near theuncinate process 42 of the patient. The turbinate protector 200 protectsthe middle turbinate 40 from damage from the distal end portion 320 ofthe guide catheter that may otherwise harm the middle turbinate. Theturbinate protector 200 also avoids damage to the turbinate from othersurgical instruments, guide wires, endoscopic imaging tools and thelike.

FIG. 5 is an endoscopic view of the human nasal passageway of FIG. 4,showing turbinate protector 200 protecting a section of theanterior/inferior portion the middle turbinate 40. Similar to the frontview shown in FIG. 3 b, the bendable portion 250 of the turbinateprotector is shown in FIG. 5 as well as portions 210 and 220. The viewprovided by FIG. 5 illustrates the close proximity of the uncinateprocess 42 to the middle turbinate 40.

Referring now to FIGS. 6 a-c, there is shown another embodiment of aturbinate protector 400 in accordance with the invention. FIG. 6 a is afront view of a turbinate protector 400 shown in an extended or flatposition. FIG. 6 b is a perspective view of the turbinate protector 400of FIG. 6 a shown in a folded position. FIG. 6 c shows the turbinateprotector 400 being held by forceps. Turbinate protector 400 may bemanufactured from a substantially flat sheet of material, which can thenbe bent, creased or folded into the configuration shown in FIG. 6 b. Theturbinate protector 400 can be easily and conveniently stored in a flator extended position before use. Materials useful in the manufacturingof turbinate 400 may include but are not limited to PEEK, nylon, PEBAX,PTFE, annealed stainless steel, NITINOL, or bioabsorbable materials,such as polymers based on polycaprolactone, PGA, PLA, or copolymers ofPGA and PLA. Turbinate protector 400 comprises first and secondsubstantially planar wing-like portions or members 410 and 420respectively, each having a proximal end portion 430 a, 440 a, and adistal end portion 430 b and 440 b, wherein the proximal end portions430 a and 440 a of the substantially planar portions 410 and 420 areconnected to one another by a resilient, bendable or malleable bridge orconnecting portion 450. While the first and second portions 410 and 420are shown as having the same relative size and shape, flat portions 410and 420 as well as bendable portion 450 may also be of different (i.e.unequal) sizes or shapes depending on the type or shape of the turbinateto be protected. The bendable or foldable portion 450 further comprisesa top portion 460 and bottom portion 470 with at least one crease orfold line(s) 480 extending between the top 460 and 470 bottom portions,to allow the turbinate protector 400 to be folded along the crease 480as shown in FIG. 6 b. In some embodiments, the bendable 450 portion ofthe turbinate protector 400 comprises a plurality of crease or foldlines 480 to conform more precisely to a particular sinus turbinate tobe protected. The crease(s) 480 may also be configured to move and/orbend the substantially planar portions 410 and 420 to their respectiveleft or right sides of the turbinate to be protected.

Turbinate protector 400 further comprises an inner side surface 490 andouter side surface 500, the inner side surface 490 configured to contactthe turbinate to be protected and the outer side 500 configured todisperse the forces generated by the impact of a surgical instrumentwhen the surgical instrument comes in contact the turbinate protector400. Inner side 490 surface may further comprise a coating of abiodegradable adhesive to aid in the positioning and temporarysecurement of the turbinate protector on the turbinate.

The turbinate protector 400 may include one or more openings 510 on flatportion 410 and a corresponding opening or openings (not shown) on flatportion 420. Openings 510 are structured to allow forceps 520 or othersurgical device to be inserted into openings 510 to allow positioning ofthe turbinate protector 400 on a turbinate. In the embodiment shown inFIG. 6 c, there are two openings or slits 510 on each of portions 410and 420, thus allowing the distal ends 530 of the forceps 520 to remainon the outer side surface 500 of the turbinate protector 400. Theopenings 510 may extend through portions 410, 420 and inner surface 490,In certain embodiments, the openings 510 do not penetrate the innersurface 490 at all. Forceps 520, when inserted into openings 510, may beused to exert an opening force on portions 410, 420 such that portions410, 420 move apart in a “clam-like” motion, with distal end portions430 b, 440 b undergoing the greatest movement, allowing the protector400 to be easily positioned over a turbinate. Removing the opening forcefrom turbinate protector by releasing forceps 520 and removing forceps520 from openings 510, results in portions 410, 420 moving together orclosing, to secure the turbinate between the protecting portions 410,420 and bridge 450.

Turbinate protector 400 may include one or more radio-opaque markers(not shown) or markers comprising magnetic material to allow the surgeonuser to visualize and position the turbinate protector 400 byfluoroscopy or other x-ray techniques during surgery.

FIG. 7 a and FIG. 7 b show yet another embodiment of a turbinateprotector 600 in accordance with the invention, wherein FIG. 7 a showsturbinate protector 600 in a forced or open position, and FIG. 7 b showsprotector 600 in a relaxed or closed position. Turbinate protector 600includes first and second protecting elements or portions 610, 620having proximal end portions 630 a, 630 b respectively, and distal endportions 640 a, 640 b respectively. First and second portions 610, 620are joined or connected by a bridge or connecting portion or section650. Also joined to connecting section 250 are opening and closingcontrol elements 660, 670.

Connecting section 650 serves as a mechanical interface between closureor control elements 660, 670 and portions 610, 620. Connecting section650 and closure elements 660, 670 are mechanically coupled or interfacedwith portions 610, 620 via connecting or bridge portion 650. Closureelements 660, 670 are structured and configured such that, byapplication of forces indicated by arrows “A” (FIG. 7 a) from forceps(not shown) or other instrument, portions 610, 620 move apart from eachother in a “pincer-like” motion to define an opening 680 (FIG. 7 a) thatallows turbinate 40 to fit between portions 610, 620 and into opening680. When the forces indicated by arrows “A” are removed by releasingelements 660, 670, the turbinate protector 600 returns to a relaxed orclosed position with portions 610, 620 surrounding and protectingturbinate 40. Connecting or bridge portion 650 may comprise a resilientmaterial, with portions 610, 620 and elements 660, 670 joined to bridgeportion 650 and structured and configured such that application offorces “A” results in suitable flexion of connecting region 650 tocommunicate forces “A” to portions 610, 620 such that portions undergoan opening motion, and such that release or removal of forces “A”results in closing of portions 610, 620 as shown in FIG. 7 a and FIG. 7b. Opening forces “A” may be applied, for example, by grasping andsqueezing elements 660, 670 with forceps or like instrument (not shown),and releasing the forceps from elements 660, 670 removes forces “A”.

In certain embodiments a pivot point mechanical assembly 690 (FIG. 7 b)may be located at connecting region 650. Mechanical interface 690 maycomprise a spring and pin assembly configured to transfer force fromelements 670, 680 to portions 610, 620 to provide opening and closing asdescribed above. Turbinate protector 600 may include radio-opaquemarkings or indicia as described above to aid the user in positioningturbinate protector 600. The inner surface (not shown) of portions 610,620 may include a bioadhesive to facilitate temporary fixation ofturbinate protector to turbinate 40 as described above.

Referring now to FIGS. 8 a and 8 b, there is shown another embodiment ofa turbinate protector 700 in accordance with the invention. FIG. 8 ashows turbinate protector 700 in a closed or relaxed position, and FIG.8 b shows the turbinate protector 700 in an open or extended position.

Turbinate protector 700 includes first and second protecting elements orportions 710, 720 having proximal end portions 730 a, 730 brespectively, and distal end portions 740 a, 740 b respectively. Abridge or connecting region or section 750 joins first and secondportions 710, 720 together. A first pair of control elements or segments760 a, 760 b are joined to connecting region 750. A second pair ofcontrol elements or segments 770 a, 770 b are respectively joined to thefirst pair of segments 760 a, 760 b by connecting regions or sections780 a, 780 b (FIG. 8 a), such that segments 760 a and 770 a are joinedby section 780 a, and segments 760 b and 770 b are joined by section 780b. In certain embodiments, segments 770 and 770 b may be joined togetherby section 780 c.

Connecting region 750 is flexible or resilient in nature such thatconnecting region 750 is mechanically interfaced with portions 710, 720and with segments 760 a, 760 b. Connecting regions 780 a, 780 b and 780c likewise are flexible or resilient and provide a mechanical couplingor interface between segments 770 a, 770 b and segments 760 a, 770 brespectively. Connecting regions 750, 780 a, 780 b and 780 c andsegments 760 a, 760 b, 770 a, 770 b are thus mechanically coupled toportions 710, 720 via bridge or connecting region 750. Connectingregions 750, 780 a, 780 b and 780 c and segments 760 a, 760 b, 770 a,770 b are structured and configured such that application of an inwardpressure or force as shown by arrows “A” (FIG. 7 b) on segments 760 a,760 b, 770 a, 770 b and/or regions 780 a, 780 b will impart or providean opening force to portions 710, 720, and release of the pressure orforce “A” from segments 760 a, 760 b, 770 a, 770 b and/or regions 780 a,780 b results in a closing motion by portions 710, 720. When in the openposition as shown in FIG. 8 b, portions 710, 720 define an opening 790that allows a turbinate (not shown) to fit between portions 710, 720. Inthe closed position shown in FIG. 8 b, the turbinate is secured betweenportions 710 and 720. Introduction and removal of forces “A” may beachieved by respectively grasping and releasing segments 760 a, 760 b,770 a, 770 b with forceps or other instrument.

In certain embodiments pivot point mechanical assemblies, such as pinand spring assembly (not shown), may be located at connecting regions750, 780 a and 780 b to provide for opening and closing of portions 710,720 in the manner described above. The inner surface (not shown) ofportions 710, 720 may include a bioadhesive to facilitate adherence tothe turbinate as described above.

FIG. 9 provides a top view of still another embodiment of a turbinateprotector 800 in accordance with the invention. The turbinate protector800 includes protecting portions or sections 810, 820 each havingproximal end portions 830 a, 830 b respectively, and distal end portions840 a, 840 b respectively. A curved or arcuate-shaped flexible bridge orconnector 850 is coupled to proximal end portions 830 a, 830 b of firstand second portions 810, 820 by first and second connecting regions 860a, 860 b. The flexible connector 850 is thus mechanically interfaced toportions 810, 820 by regions 860 a, 860 b.

The turbinate protector 800 of FIG. 9 is shown in a closed position.Application of an opening force as indicated by arrows “A” on connector850, using forceps or other instrument as described above, causesconnector 850 to flex or bend in the direction indicated by arrow “B”,which imparts an opening motion to portions 810, 820, such that portions810, 820 move apart to an opened position (not shown). In the openedposition, a turbinate (not shown) can access opening or cavity 870, andwhen in the closed position, the turbinate protector 800 is held inposition on the turbinate by portions 810, 820.

FIG. 10 shows another embodiment of a turbinate protector 900 inaccordance with the invention. The turbinate protector 900 comprisesprotecting portions or sections 910, 920, and a curved or arcuate-shapedflexible bridge or connector 930 joined to portions 910, 920. In theembodiment of FIG. 10, portions 910, 920 and connecting region 930define a contiguous cylindrical shape with a slot 940 between the distalend portions 950 a, 950 b of portions 910, 920 respectively. In theembodiment of FIG. 10, application of an opening force or forcesrepresented by arrows “A” results in an opening motions such that thedistal end portions 950 a, 950 b move apart and widen slot 940 so that aturbinate (not shown) can fit through slot 940 and into opening 960between portions 910, 920. Removal of the opening force results in aclosing motion such that portions 910, 920 move together, so that theturbinate is secured within opening by end portions 950 a, 950 b. Theopening force may be applied to the turbinate protector 900 by insertingforceps or like instrument (not shown) into opening 960 and exerting anopening force as indicated by arrows “A”.

Referring now to FIG. 11, there is shown a flow chart illustrating stepsthat may be performed according to an embodiment of a method of thepresent invention. In event 1010, introducing a turbinate protectingdevice into a patient is carried out. The introducing may comprise, forexample, inserting the turbinate protector through the nostril 80 (FIG.2) and nasal passage of a patient using forceps 520 (FIG. 6 c) or otherinstrument.

In event 1020, a target turbinate is located. The locating may comprise,for example, visualizing the selected or target turbinate via endoscopicimaging.

In event 1030, the turbinate protector is positioned on the targetturbinate. The positioning may comprise, for example, positioning firstprotecting portion 210 (FIG. 3 a-3 c) of turbinate protector 200adjacent or proximate to a first side of turbinate 40, positioningsecond protecting portion 220 of turbinate protector 200 adjacent orproximate to a second side of turbinate 40, and positioning connectingor bridge region 250 adjacent or proximate to the anterior or inferiorportion of turbinate 40. The positioning may further comprise contactingturbinate 40 with inside surface 270, which may optionally include abioadhesive as described above, such that the positioning furthercomprises securing the inside surface of the turbinate protector to theturbinate with a bioadhesive located on the inner surface. Thepositioning may be carried out using forceps 520 (FIG. 6) or likesurgical instrument.

In certain embodiments such as those illustrated in FIGS. 6 a-6 c, thepositioning 1030 may comprise moving the first and second portions 410,420 of the turbinate protector 400 to an open position, positioning thetarget turbinate between the first and second portions 410, 420, andmoving the first and second portions 410, 420 to a closed position. Theopening of portions 410, 420 may, in certain embodiments, compriseapplying an opening force to portions 410, 420, and the closing maycomprise removing the opening force from portions 410, 420. In otherembodiments the opening of portions 410, 420 may comprise applying anopening force bridge portion 450, and the closing of portions 410, 420may comprise removing the opening force from the bridge portion 450.

More particularly, the positioning may comprise moving the first andsecond portions 410, 420 of the turbinate protector 400 to an openposition, positioning the target turbinate between the first and secondportions 410, 420, positioning the first portion 410 adjacent to a firstside of the turbinate, positioning the second portion 420 adjacent to asecond side of the target turbinate, positioning the bridge portion 450adjacent to an anterior or inferior portion of the turbinate, and movingthe first and second portions 410, 420 to the closed position.

In another embodiment, the positioning 1030 may comprise applying anopening force to control elements 660, 670 (FIG. 7 a) of turbinateprotector 600 to open or move portions 610, 620 apart, positioning theturbinate 40 within the opening 680, positioning first portion 610 ofturbinate protector 600 adjacent or proximate to a first side ofturbinate 40, positioning second portion 620 of turbinate protector 600adjacent or proximate to a second side of turbinate 40, positioningconnecting or bridge region 650 adjacent or proximate to the anterior orinferior portion of turbinate 40, and removing the opening force fromcontrol elements 610, 620. The positioning may further comprisecontacting an inner surface of protector 600 with turbinate 40. Applyingthe opening force to control elements 660, 620 may comprise graspingcontrol elements 660, 670 with forceps, and removing the force fromcontrol elements 660, 670 may comprise releasing control elements 660,670.

In event 1040, paranasal surgery is performed. Performing paranasalsurgery may comprise carrying out a variety of surgical techniques oroperations, including FESS and FTSI surgeries as described above.

In event 1050, the turbinate protecting device is removed from theturbinate and the patient. The removing in many embodiments may compriseopening the first and second portions of the protector to release theturbinate, and withdrawing the turbinate protector from the patientnasal cavity via the nostril using a suitable surgical instrument.Alternatively, if the turbinate protector is made from a bioabsorbablepolymer, it may be left in place and allowed to dissolve over time.

While the present invention has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

What is claimed is:
 1. A method for protecting a turbinate, comprising:introducing a turbinate protector into a patient; locating a targetturbinate; positioning a turbinate protector on the target turbinate;wherein the positioning comprises: positioning a first protectingportion of the turbinate protector adjacent to a first side of theturbinate; positioning a second protecting portion of the turbinateprotector adjacent to a second side of the turbinate; positioning abridge region of the turbinate protector adjacent to the anterior orinferior portion of the turbinate; performing paranasal surgery; andremoving the turbinate protector from the patient.
 2. The method ofclaim 1, wherein the introducing of the turbinate protector comprisesinserting the turbinate protector through the nasal passage of thepatient.
 3. The method of claim 1, wherein the locating comprisesvisualizing the selected or target turbinate via endoscopic imaging. 4.The method of claim 1, wherein the locating comprises visualizing theselected or target turbinate by fluoroscopic imaging utilizing aradio-opaque marker on the turbinate protector.
 5. The method of claim1, wherein the positioning further comprises contacting the turbinatewith an inside surface of the turbinate protector.
 6. The method ofclaim 5, further comprising securing the inside surface of the turbinateprotector to the turbinate with a bioadhesive located on the innersurface.
 7. The method of claim 1, wherein the positioning comprises:moving the first and second protecting portions of the turbinateprotector to an open position; positioning the target turbinate betweenthe first and second protecting portions; and moving the first andsecond protecting portions to a closed position.
 8. The method of claim7, wherein the positioning further comprises: applying an opening forceto the first and second protecting portions to move the first and secondportions to the open position; and removing the opening force from thefirst and second protecting portions, to move the first and secondprotecting portions to the closed position.
 9. The method of claim 7,wherein the positioning further comprises: applying an opening force tothe bridge region to move the first and second portions to the openposition; and removing the opening force from the bridge region, to movethe first and second protecting portions to the closed position.
 10. Themethod of claim 7, wherein the positioning further comprises:positioning the first protecting portion adjacent to a first side of theturbinate; positioning the second protecting portion adjacent to asecond side of the turbinate; and positioning the bridge region adjacentto an anterior or inferior portion of the turbinate.
 11. The method ofclaim 7, wherein the positioning further comprises: applying an openingforce to first and second control elements, the first and second controlelements being mechanically coupled to the first and second protectingportions; and removing the opening force from the control elements. 12.The method of claim 1, wherein the performing paranasal surgerycomprises performing an FESS surgery.
 13. The method of claim 1, whereinthe performing paranasal surgery comprises performing an FTSI surgery.14. The method of claim 1, wherein the removing comprises opening thefirst and second protecting portions; releasing the turbinate from theturbinate protector; and withdrawing the turbinate protector from thepatient nasal cavity via the nostril.